FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120529–120552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1991
MICRO ALBUMIN EIA TEST KIT
K912543 · JIR
Immuno Diagnostic Center, Inc.
Chemistry · 39d
Cleared Jul 19, 1991
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · BYG
Salter Labs
Anesthesiology · 35d
Cleared Jul 19, 1991
SURGICAL SAW BLADES
K912761 · GFA
Blairden Precision Instruments, Inc.
General & Plastic Surgery · 25d
Cleared Jul 19, 1991
PERRY NATURAL POWDER FREE GLOVES
K912797 · KGO
Smith & Nephew, Inc.
General Hospital · 24d
Cleared Jul 18, 1991
FUTURECARE CARELYNK IV SYSTEM
K903512 · DRT
Futurecare Systems, Inc.
Cardiovascular · 349d
Cleared Jul 18, 1991
DATAMED MODEL 401A TRANSRECIEVER
K904966 · DXH
Datamed, Inc.
Cardiovascular · 255d
Cleared Jul 18, 1991
MODEL 8604-FO PULSE OXIMETER
K910001 · DQA
Nonin Medical, Inc.
Anesthesiology · 197d
Cleared Jul 18, 1991
IPI ALGO-LINE CATHETER
K911382 · MAJ
Pudenz-Schulte Medical Research Corp.
General Hospital · 112d
Cleared Jul 18, 1991
INJECTOR FILL TUBE
K911549 · DXT
The R Group
Cardiovascular · 101d
Cleared Jul 18, 1991
MAGNETIC HDL CHOLESTEROL TEST
K911906 · LBR
Reference Diagnostics, Inc.
Chemistry · 79d
Cleared Jul 18, 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · CFR
King Diagnostics, Inc.
Chemistry · 58d
Cleared Jul 18, 1991
CALCITONIN KIT MITSUBISHI YUKA
K912536 · JKR
Mitsubishi Yuka America, Inc.
Chemistry · 41d
Cleared Jul 18, 1991
K-CAP-I, STERILE
K912762 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 24d
Cleared Jul 17, 1991
CARDIOCAP CMX-104 MONITOR
K903237 · DXN
Datex Division Instrumentarium Corp.
Cardiovascular · 359d
Cleared Jul 17, 1991
DERMALIGHT PSORACOMB
K903660 · IOB
Solitec GmbH
Physical Medicine · 341d
Cleared Jul 17, 1991
TOWNLEY TOTAL KNEE (TTK)
K904448 · JWH
Biopro, Inc.
Orthopedic · 292d
Cleared Jul 17, 1991
VITALMAX 2100/2200
K905274 · DRT
Pace Tech, Inc.
Cardiovascular · 244d
Cleared Jul 17, 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · LDD
Physio-Control Corp.
Cardiovascular · 184d
Cleared Jul 17, 1991
Q-SMART HOLTER SYSTEMS
K910808 · DSI
Quinton, Inc.
Cardiovascular · 141d
Cleared Jul 17, 1991
NUTIP (TM) SYRINGE SHIELD
K911214 · EKJ
Western M/D, Inc.
Dental · 120d
Cleared Jul 17, 1991
HEPCON HMS WITH BODY SURFACE AREA CALCULATION
K911240 · JOX
Hemotech, Inc.
Hematology · 118d
Cleared Jul 17, 1991
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · LYK
Olympus Corp.
Cardiovascular · 114d
Cleared Jul 17, 1991
VZV IGM TEST
K911301 · GQX
Gull Laboratories, Inc.
Microbiology · 114d
Cleared Jul 17, 1991
GUM MASSAGER
K911418 · JET
Burn-Henderson Partnership
Dental · 107d